U.S. patent application number 10/073737 was filed with the patent office on 2003-05-22 for spray device.
Invention is credited to Buono, Lawrence M..
Application Number | 20030097117 10/073737 |
Document ID | / |
Family ID | 26754833 |
Filed Date | 2003-05-22 |
United States Patent
Application |
20030097117 |
Kind Code |
A1 |
Buono, Lawrence M. |
May 22, 2003 |
Spray device
Abstract
A spray or delivery device is arranged to dispense a dye into
the anterior chamber of a human eye or other mammalian eye for the
purpose of staining a specific ocular structure or tissue. An
ocular structure of particular interest is the anterior lens
capsule. The spray device includes a cannula having a distal end
arranged for insertion into the anterior chamber of the eye. The
cannula preferably has a dispensing orifice located at a side of
the cannula offset from the distal end. The orifice preferably
dispenses the fluid dye or stain in spray form. In one exemplary
embodiment, the cannula has a fin extending radially outward from
the cannula. In another exemplary embodiment, the cannula has a
flared sleeve surrounding and extending from the orifice. In a
method for conducting intra-ocular surgery, said delivery device
would dispense a dye in a particular fashion so as to control its
application to the intended target tissue, thereby limiting
delivery of the dye to undesired surrounding tissue structures.
Inventors: |
Buono, Lawrence M.;
(Philadelphia, PA) |
Correspondence
Address: |
CAESAR, RIVISE, BERNSTEIN,
COHEN & POKOTILOW, LTD.
12TH FLOOR, SEVEN PENN CENTER
1635 MARKET STREET
PHILADELPHIA
PA
19103-2212
US
|
Family ID: |
26754833 |
Appl. No.: |
10/073737 |
Filed: |
February 11, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60334470 |
Nov 16, 2001 |
|
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|
Current U.S.
Class: |
604/521 ;
604/188 |
Current CPC
Class: |
A61F 9/0017 20130101;
A61M 5/3286 20130101; G01N 1/31 20130101; A61M 5/3291 20130101;
A61M 2005/341 20130101 |
Class at
Publication: |
604/521 ;
604/188 |
International
Class: |
A61M 031/00 |
Claims
I claim:
1. A spray device arranged to deliver a fluid into an eye,
comprising a reservoir arranged to house the fluid to be delivered,
a cannula having a distal tip for insertion into the eye, said
cannula in fluid communication with said reservoir and having an
orifice located inward of said distal tip, and a pressurizer
arranged to move the fluid from said reservoir through said orifice
to an intra-ocular structure within the eye.
2. The device of claim 1, wherein the cannula is constructed so as
to allow for the control of the direction of the fluid
delivery.
3. The device of claim 2, wherein the cannula is arranged to
deliver the fluid into the anterior chamber of the eye, and the
orifice is located a predetermined distance from the distal
tip.
4. The device of claim 2, said orifice including a sleeve
surrounding and extending from said orifice in a direction desired
for the fluid delivery.
5. The device of claim 4, wherein said sleeve is flared outward
from said orifice.
6. The device of claim 2, said cannula having a distal portion
extending from a location inward of said orifice to said distal
tip, said device further comprising a fin extending longitudinally
around said distal portion.
7. The device of claim 1, said cannula arranged for facilitating
controlled dispersion of the fluid.
8. The device of claim 1, said pressurizer including a plunger
inserted into said reservoir and arranged to deliver a specified
aliquot of the fluid to the anterior chamber.
9. The device of claim 1, wherein the fluid is a dye or stain in
liquid, aqueous, or gel form.
10. The device of claim 1, wherein said orifice is arranged to
deliver the fluid towards the anterior lens capsule.
11. The device of claim 1, said reservoir including a cannula hub
attached to said cannula.
12. The device of claim 11, further comprising an elbow at a bend
in said cannula between said cannula hub and said distal tip.
13. The device of claim 1, wherein said orifice is structured to
deliver the fluid in a spray form.
14. The device of claim 1, further comprising the fluid contained
in said reservoir that is delivered into the eye.
15. The device of claim 14, wherein the fluid contained in said
reservoir is indigo carmine.
16. A method for delivering a fluid to an intra-ocular structure
with a spray device having the fluid in a reservoir, a cannula in
fluid communication with the reservoir and having a distal tip and
an orifice located inward of the distal tip, and a pressurizer
arranged to move the fluid from the reservoir through the orifice,
the method comprising: a) inserting the cannula through an opening
of an eye; b) aligning the orifice over the intra-ocular structure;
and c) spraying the intra-ocular structure with the fluid by moving
the fluid from the reservoir through the orifice.
17. A spray device arranged to deliver a fluid into a cavity,
comprising a reservoir arranged to house the fluid to be delivered,
a cannula having a distal tip for access into the cavity, said
cannula in fluid communication with said reservoir and having an
orifice located inward of said distal tip, and a pressurizer
arranged to move the fluid from said reservoir through said orifice
to a tissue within the cavity.
18. The device of claim 17, said orifice including a sleeve
surrounding and extending from said orifice in a direction desired
for the fluid delivery.
19. The device of claim 18, wherein said sleeve is flared outward
from said orifice.
20. The device of claim 17, said cannula having a distal portion
extending from a location inward of said orifice to said distal
tip, said device further comprising a fin extending longitudinally
around said distal portion.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to a device arranged for
spraying or dispersing a fluid (e.g., a stain or dye). In
particular, this invention relates to a delivery device arranged
for spraying or dispensing the fluid to an intra-ocular surface in
the anterior chamber of a human eye or another mammalian eye as
part of a diagnostic or therapeutic endeavor (e.g., cataract
surgery).
BACKGROUND OF THE INVENTION
[0002] During intra-ocular surgery it is often desirable to
distinguish between different intra-ocular structures. One means of
accomplishing this desired effect is to use an adjuvant dye or
stain to differentiate between different structures. There are
several different types of dyes used to stain intra-ocular
structure, including but not limited to fluorescein, indocyanine
green, methylene blue, and trypan blue. A list of some other
possible dyes includes indigotindisulfonate, rose bengal, patent
blue V, sulphan blue, tolonium chloride, lissamine green, brilliant
blue, carbanthrene blue, erythrosine, and alphazurine.
[0003] One type of such an intra-ocular surgery is cataract
surgery. In modern cataract surgery, it is desirable to easily
distinguish the anterior lens capsule from surrounding structures
and perform a continuous curvilinear capsulorrhexis so that the
natural lens can be removed by phacoemulsification or other methods
and replaced with an artificial lens.
[0004] A method of cataract surgery is as follows. A small
paracentesis incision is made peripherally into the clear cornea.
The aqueous humor of the anterior chamber is subsequently drained
and replaced with air. A dye is then applied to the anterior lens
surface (e.g., anterior lens capsule) using a delivery device
(e.g., a syringe). The dye is allowed to contact the lens surface
for an amount of time sufficient to stain that surface. Optionally,
the dye solution is drained or irrigated (using balanced salt
solution) from the anterior chamber. Next, the anterior chamber is
filled with an optically clear viscoelastic polymer (e.g.,
hyaluronate, chondroitin sulfate). A rent is made in the anterior
lens capsule using a cystotome and a continuous curvilinear
capsulorrhexis is the made under direct visualization of the
stained anterior lens capsule. Removal of the natural lens material
may be accomplished by a variety of methods including
phacoemulsification.
[0005] In the above-outlined step of removing the aqueous humor
from the anterior chamber and replacing it with air, the lens
assumes a convex configuration. This occurs because the fluid from
the anterior chamber is replaced with air and the pressure in this
compartment of the eye is lower than the pressure in the vitreous
compartment of the eye and the lens is pushed forward. This
physical phenomenon of the lens assuming a convex configuration can
cause difficulty with the application of a dye or stain to the
anterior lens capsule surface.
[0006] When the fluid dye or stain is applied to the anterior lens
surface of an air-filled anterior chamber, it tends to roll off to
one side and collect in the gutter space created by the iris lens
interface and the angle of the anterior chamber. Because of this,
the dye or stain must be massaged into the capsule to achieve
adequate staining. This maneuver of massaging the dye into the lens
capsule causes the risk of inadvertently tearing the capsule and
thereby complicating the remainder of the surgical procedure. Also,
a larger volume than is necessary to adequately stain the lens
capsule must be utilized.
[0007] Furthermore, the current method of delivering a fluid dye or
stain to the anterior chamber to stain the anterior lens capsule is
accomplished in an uncontrolled fashion. The dye or stain is
applied to the surface of the anterior lens capsule for an amount
of time sufficient to stain that surface. Because of the current
design of the tip of the cannula, the dye or stain encounters
intra-ocular structures that are not intended and may have a
deleterious effect, including a toxic effect as well as diminishing
the effect of selective staining.
BRIEF SUMMARY OF THE INVENTION
[0008] The preferred delivery devices are arranged to dispense a
dye or stain in a controlled fashion to a target tissue or
structure (e.g., anterior lens capsule) located in the anterior
chamber of an eye for differentiating the target tissue or
structure during a surgical procedure or any diagnostic or
therapeutic endeavor. The device is designed to control the area to
which the dye or stain can be delivered, thereby eliminating
detrimental effects resulting from dispensing the dye or stain in
an undesired area. The delivery device is constructed to have the
dye or stain exit from an orifice located on an inferior surface of
the cannula as opposed to a currently used dispensing orifice
located at the distal tip of the cannula. This new location allows
an operating surgeon to more precisely control the area to which
the dye or stain is applied, thereby sparing the neighboring
intra-ocular structures from unwanted staining. A preferred dye for
staining the target tissue or structure is indigo carmine, as
discovered by the inventor of the present invention.
[0009] In an exemplary embodiment, a dispensing device arranged to
deliver a fluid into an eye includes a reservoir, a cannula and a
pressurizer. The reservoir is arranged to house the fluid to be
delivered. The a cannula has a distal tip for insertion into the
eye, is in fluid communication with the reservoir and includes an
orifice located inward of the cannula's distal tip. The pressurizer
(e.g., plunger or mechanism that applies pressure into the
reservoir) is arranged to move the fluid from the reservoir through
the orifice to an intra-ocular structure within the eye.
[0010] The cannula has a distal portion extending from a location
inward of the orifice to the distal tip. As such, the device may
also include a fin extending longitudinally around the distal
portion. Further, the orifice may include a sleeve surrounding and
extending from the orifice in a direction desired for the fluid
delivery. Preferably, this sleeve is flared outward from the
orifice.
[0011] Moreover, the orifice of the invention is preferably
designed to disperse the dye or stain in a spray form rather than
stream form, so as to allow the dye or stain to better adhere to
the tissue or structure. In other words, the orifice is preferably
arranged with an opening having a size and shape sufficient to
discharge liquid in spray form. This feature obviates the need to
massage the dye into the lens capsule and prevents the possibility
of the complication of inadvertently tearing the lens capsule.
Also, this spray feature further prevents the dye or stain from
leaking onto adjacent tissue; thereby staining tissue or structures
not intended to be stained. This spray feature also allows for
delivery of a smaller amount of the dye or stain to the
intra-ocular compartment, thereby reducing any potential toxic
effect of the dye or stain.
[0012] In another exemplary embodiment, a method for delivering a
fluid to an intra-ocular structure is disclosed. The method uses a
spray device having the fluid in a reservoir, a cannula in fluid
communication with the reservoir and having a distal tip and an
orifice located inward of the distal tip, and a pressurizer
arranged to move the fluid from the reservoir through the orifice.
The method includes inserting the cannula through an opening of an
eye, aligning the orifice over the intra-ocular structure, and
spraying the intra-ocular structure with the fluid by moving the
fluid from the reservoir through the orifice.
[0013] In yet another exemplary embodiment, a spray device arranged
to deliver a fluid into a cavity includes a reservoir, a cannula
and a pressurizer. The reservoir is arranged to house the fluid to
be delivered. The cannula has a distal tip for access into the
cavity, is in fluid communication with the reservoir, and includes
an orifice located inward of the distal tip. The pressurizer is
arranged to move the fluid from the reservoir through the orifice
to a tissue within the cavity.
[0014] The described characteristics of the invention are easily
discernable from the drawings. Moreover, further scope of
applicability of the present invention will become apparent in the
description given hereafter. However, it should be understood that
the detailed description and specific examples, while indicating
preferred embodiments of the invention, are given by way of
illustration only, since the invention will become apparent to
those skilled in the art from this detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The invention will be described in conjunction with the
following drawings, in which like-referenced numerals designate
like elements, and wherein:
[0016] FIG. 1 is a top view of the invention including the
reservoir and dispensing cannula with characteristic shape in
accordance with an exemplary embodiment of the invention;
[0017] FIG. 2 is a partial side view of the cannula illustrated in
FIG. 1;
[0018] FIG. 3 is a partial top view of the cannula shown in FIG.
1;
[0019] FIG. 4 is a partial side view of a cannula in accordance
with another exemplary embodiment of the invention;
[0020] FIG. 5 is a partial top view of the cannula illustrated in
FIG. 4; and
[0021] FIG. 6 is a top view of the cannula of FIG. 3 shown
partially inserted in an anterior chamber of a human eye.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0022] This invention includes a spray device that delivers a fluid
(e.g., a dye or stain) in a precise and controlled manner. A user
controls the direction of delivering the dye or stain by directing
the dispensing orifice. In one embodiment flared extensions on the
sides of the cannula prevent the dye or stain from dispersing in a
retrograde fashion. In another embodiment a flared sleeve around
the dispensing orifice assists in controlled delivery of the dye or
stain.
[0023] The spray device preferably delivers the fluid in spray
form. While not being limited to a particular theory, the term
spray form generally refers to fine droplets or vapor that scatter
or fall from the orifice. In the exemplary embodiments described
below the spray is generally a fluid moved by pressure out of the
orifice. Example forms of spray include but are not limited to:
aerosol, mist, atomized, rarified liquid, droplets, vapor, drizzle,
froth, fog, splash, or sprinkle.
[0024] The term distal refers to the end or direction of the device
that is applied toward an injection site for delivery. The term
proximate refers to the end or direction of the device that is
opposite the distal end. The structural elements described in the
exemplary embodiments can by formed of any suitable material, e.g.
plastic, metal, rubber.
[0025] Referring to FIG. 1, a spray device is schematically
illustrated at 10. The device 10 includes a reservoir 12, a plunger
14, and a cannula 16. The reservoir 12 is designed to store the dye
or stain fluid that is intended to be delivered into the anterior
chamber. Without being limited to a particular theory, the
reservoir 12 is generally cylindrical in shape and has a surface 18
preferably with calibrated markings 20 imprinted thereon. The
reservoir 12 is preferably constructed, at least in part, of a
material that allows a user to see and measure fluid contained in
the reservoir 12, such as a transparent or translucent plastic.
[0026] The plunger 14 extends within a first end 22 of the
reservoir 12. The plunger 14 is mobile and is used as a pressurizer
to assert pressure within the reservoir 12. While the plunger 14 is
shown in FIG. 1 as having a particular form, a skilled artisan
would readily understand that the plunger 14 could be of any
mechanical, electrical or chemical form that allows the plunger 14
to assert pressure within the reservoir 12. As such, the plunger 14
can be separable or integral with the reservoir 12, and may have
contact with other elements as desired to assert the pressure.
[0027] Referring in particular to FIG. 1, the reservoir 12 has a
second end 24 with a cannula hub 26 that holds the cannula 16.
Preferably the cannula hub 26 includes threads that allow for a
coupling with opposing threads of the cannula 16. That is, the
proximate end of the cannula 16 is arranged to be screwed into the
threads of the cannula hub 26.
[0028] The cannula 16 includes a tip 28 and an orifice 30. The tip
28 is located at the distal end of the cannula 16, and is closed.
That is, the tip 28 does not have an opening for dispensing fluid.
While not being limited to a particular theory, a user (e.g.,
surgeon) cuts an incision in an eye and the cannula 16 is inserted
into the eye through the incision. Accordingly, the cannula 16 is
not used to poke through layered tissue. Because the cannula 16 is
inserted through an existing incision, the tip 28 is preferably
blunt. In fact, the tip 28 should be blunt and rounded to avoid
accidental harm caused if the tip 28 was pressed or placed in
contact with another object.
[0029] While not being limited to a particular theory, the cannula
16 is preferably a cylindrical hollow tube. As best seen in FIGS.
1, 3, 5 and 6, the body of the cannula 16 bends at an elbow 26
inward of the distal tip 28. The degree of the angle at the elbow
26 may be variable as desired with preferred angulation between
about 15 degrees and about 60 degrees. The cannula 16 is bent at
the elbow 26 to make it easier for a user (e.g., surgeon) to hold
and control the spray device 10 during fluid delivery into an eye.
In operation, the reservoir 12 and plunger 14 are arranged to
extend away from the face of the patient, thereby keeping the
user's fingers away from the patient's face. However, it is
understood that the device 10 would work even if the cannula 16
were substantially straight along its entire length.
[0030] The dispensing orifice 30 is located inward of the tip 28 on
the underside of the cannula 16. The orifice 30 is located on the
underside of the cannula 16 to control the direction of delivery
toward a specific intra-ocular structure, such as the anterior lens
capsule in the anterior chamber. While not being limited to a
particular distance, the orifice 30 is positioned a predetermined
distance from the tip 28, preferably ranging from about 1 mm to
about 3 mm inward of the tip 28. The orifice 30 is of sufficient
size to dispense the fluid dye or stain in an spray fashion, as
readily understood by a skilled artisan.
[0031] FIGS. 2 and 3 illustrate a cannula 16 in accordance with an
exemplary embodiment of the invention. As best seen in FIG. 2, the
cannula 16 is attached to a fin 34 (e.g., flared extension)
longitudinally attached to the sides and distal tip 28 of the
cannula 16. The fin 34 is arranged to prevent the spray fluid dye
or stain from projecting upward opposite the underside of the
cannula 16. Accordingly, the fin 34 provides the benefit of
preventing dispensed fluid from projecting away from the intended
delivery site (e.g., anterior lens), thereby allowing for more
controlled delivery of the fluid dye or stain. Preferably, the fin
34 extends away from the cannula 16 by a predefined distance at a
plane substantially perpendicular to the underside of the cannula.
The preferred distance is about 1 mm from the cannula tip 28, but
may be constructed to be larger or smaller as desired. It is
understood that the cannula 16 may be constructed without the fin
34 for situations where the cannula must be inserted through an
incision too small to readily accept the fin 34.
[0032] FIGS. 4 and 5 illustrate a cannula 16 in accordance with
another exemplary embodiment of the invention. Referring to FIGS. 4
and 5, a sleeve 36 surrounding the orifice 30 extends from the
orifice 30 in a direction desired for the fluid delivery to further
control the direction of the dye or stain dispersion. As shown by
example in FIG. 5, the sleeve 36 extends a predefined distance from
the base of the cannula 16 and projects outward at a flared angle.
The preferred distance that the sleeve 36 projects from the cannula
16 is about 0.25 mm, although it is understood that the preferred
distance depends on various factors, including the size of the
cannula 16, the orifice 30, and incision.
[0033] The cannula 16 shown in FIGS. 4 and 5 is substantially
similar to the cannula 16 shown in FIGS. 2 and 3. However, the
cannula 16 shown in FIGS. 4 and 5 includes the sleeve 36
surrounding and extending from the orifice 30 in a direction
desired for the fluid delivery, whereas the cannula 16 shown in
FIGS. 2 and 3 includes the fin 34 extending longitudinally around
its distal portion, as described in more detail above. It is
understood that the spray device 10 could be constructed at least
with either the sleeve 36 or the fin 34, or with both the sleeve 36
and the fin 34.
[0034] In FIG. 6, an exemplary delivery device 10 in accordance
with the invention is illustrated in use during an operation, such
as cataract surgery. During cataract surgery, a natural anterior
lens 38 of an eye 40 is removed while leaving a lens capsule 42 in
its natural anatomic location, and an artificial lens is inserted
in place of the natural lens 38. To make the anterior lens 38 more
easily visible to a surgeon, a fluid dye is delivered to a surface
44 of the lens to stain the surface. This can be accomplished by
first draining aqueous fluid from an anterior chamber 46 of the eye
40 to provide an air-filled anterior chamber 46, and then by
delivering the fluid dye into the air-filled chamber 46. The dye is
allowed to contact the lens surface 44 for an amount of time
sufficient to stain the surface 44, and then traditionally the
excess dye may be drained out.
[0035] Referring to FIG. 6, the spray device 10 is shown with a
portion of the cannula 16 inserted into the anterior chamber 46. In
this procedure, the cannula 16 is inserted through a small
paracentesis incision 48 at the cornea 50 of the eye 40. As shown
in FIG. 6, the orifice 30 and flared sleeve 36 are preferably
aligned between an iris 52 of the eye 40 for dispersing the fluid
dye or stain onto the anterior lens surface 44. The fin 34 is also
provided for preventing the fluid dye or stain from projecting
upward opposite the dispensing orifice 30 side of the cannula 16
upon delivery of the fluid.
[0036] In operation, the user (e.g., surgeon) moves the plunger 14
into the reservoir 12, which moves fluid from the reservoir 12
through the cannula 16 and out of the orifice 30 onto the anterior
lens surface 44 to stain the surface. Since the fluid dye is
delivered directly to the lens surface 44, the fluid is more
efficiently and more effectively delivered. Therefore there is no
need to dispense excess amounts of dye as before to ensure that the
lens 38 will be sufficiently stained. Accordingly there is no need
for the additional step of draining excess fluid because there
should be no more than an insubstantial amount of excess fluid in
the anterior chamber 46.
[0037] The spray delivery device 10 of the invention thus makes it
possible to control the dispersion of a fluid dye or stain during a
surgical procedure or any diagnostic or therapeutic endeavor on a
human or other mammalian eye 40. A skilled artisan would readily
understand that the spray device could also be used during
procedures in other areas, such as in medical procedures (e.g.,
dentistry, gynecology) where it is desirable to deliver a fluid to
a particular region in a gaseous or air-filled environment.
[0038] It should be apparent from the aforementioned description
and attached drawings that the concept of the present application
may be readily applied to a variety of preferred embodiments,
including those disclosed herein. For example, the cannula 16 shown
in FIG. 2 could be constructed at least: with a sleeve 36
surrounding the orifice 30 as shown in FIG. 5, with a smaller
sleeve 36 as shown in FIG. 3, or without a sleeve 36. Naturally,
variant embodiments of the device of the invention can be used,
providing they perform the same or equivalent functions as
described above. Without further elaboration, the foregoing will so
fully illustrate the invention that others may, by applying current
or future knowledge, readily adapt the same for use under various
conditions of service.
* * * * *